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510(k) Data Aggregation

    K Number
    K211719
    Device Name
    ZinRom Nitrile examination gloves
    Date Cleared
    2021-10-06

    (124 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changzhou Xingrong Medical Technology Co. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (S"), medium (M"), large (L"), X-large (XL") for optional. The gloves are provided with blue color. The examination glove is smooth surface and a rolled rim at the cuff edge. The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
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